Status:
RECRUITING
Responding to AF: Pill-in-Pocket Anticoagulation Guided by Automated Monitoring and Alerts
Lead Sponsor:
Oxford University Hospitals NHS Trust
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation (AF)
Atrial Fibrillation (Prevention of Stroke)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting 1-2 million people in the UK. AF is characterised by uncoordinated electrical activation and ineffective contraction...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the trial.
- Understand the risk and willing to discontinue oral anticoagulation (OAC).
- Any gender aged 18 years or above.
- Non-valvular paroxysmal atrial or persistent atrial fibrillation (AF) with a current rhythm control strategy. Paroxysmal patients must have \< 3 documented or symptomatic episodes of \>1 hour duration in the previous 3 months. Persistent patients must have been in continuous sinus rhythm for at least 4 weeks prior to enrolment.
- CHA2DS2-VASc score between 1 and 3 in men and between 2 and 4 in women.
- Able to take direct-acting oral anticoagulant (DOAC) in guideline recommended doses.
- Left atrial (LA) diameter on echocardiogram less than 5 cm (anteroposterior dimensions) or LA volume less than 48 ml/m2.
Exclusion
- Any contraindication to OAC therapy with a DOAC in guideline recommended doses.
- Mechanical heart valve prosthesis or moderate-to-severe mitral valve stenosis.
- Permanent atrial fibrillation.
- Hypertrophic cardiomyopathy.
- Documented previous thromboembolic event (stroke, transient ischaemic attack or systemic embolism).
- Spontaneous echo contrast observed in any imaging modality.
- History of intracardiac thrombi.
- History of congenital heart disease.
- Severe chronic renal disease (eGFR \<15 ml/m) or on renal replacement therapy.
- Pregnant or planning pregnancy.
- Indication for OAC other than atrial fibrillation.
- Inability to comply with protocol.
- Smartphone with operating system (OS) not compatible with MyCareLink Heart app.
- Contraindication for implantable cardiac monitor.
- Visual or physical impairment that prevents ability to read and acknowledge smartphone/watch notifications.
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06922695
Start Date
April 14 2025
End Date
April 15 2027
Last Update
April 23 2025
Active Locations (1)
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1
Oxford University Hospitals NHS Trust, John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU